GSK, Theravance unveil 2nd PhIII trial for COPD trio

GlaxoSmithKline and Theravance have kicked off a second global Phase III study to assess a ‘closed’ triple combination of fluticasone furoate/umeclidinium/vilanterol in patients with chronic obstructive pulmonary disease.

The FULFIL trial, which aims to enrol around 1,800 patients, will look at whether the inhaled corticosteroid, long-acting muscarinic antagonist and long-acting beta2-adrenergic agonist combination, delivered via GSK’s Ellipta inhaler, can improve lung function and health-related quality of life compared with budesonide/formoterol, a twice-daily ICS/LABA combo delivered via the Turbohaler.

Secondary objectives include investigating the effect on the rate of exacerbations and the safety profile versus the comparator, the firms said.

The earlier Phase III IMPACT trial was launched in July last year to determine whether FF/UMEC/VI can cut the rate of moderate and severe exacerbations compared with two approved once-daily COPD treatments, Relvar/Breo Ellipta (FF/VI) and Anoro Ellipta (UMEC/VI).

Commenting on the rationale behind the trio, Dave Allen, Head of GSK Respiratory Therapy Area Unit, R&D, said “by providing all three medicine components in a single inhaler we hope to offer more convenient dosing to patients, reduce the risk of exacerbation compared to dual therapy and, as a result, contribute to the improved management of their disease”.